As appeared in July 2020 Tablets & Capsules
Copyright CSC Publishing www.tabletscapsules.com
tablet tooling
A common vocabulary: The Tableting Specification
Manual’s role in an ever-changing industry
In this article, experts describe the benefits of the Tableting Speci-
fication Manual to tablet manufacturers and equipment suppliers
and discuss aspects of the manual that may be due for an update.
T
he Tableting Specification Manual (TSM), published by the
American Pharmacists Association (APhA), is the authori-
tative reference for tablet and tablet tooling specifications
in North America. In addition to tooling specifications,
the TSM includes information on compression tooling
Nate Todd
Editor
Courtesy of Wilson Tool
terminology, tablet manufacturing, tooling and tablet
design, tool steels, maintenance, and troubleshooting.
The manual was first published in 1971 and was ini-
tially referred to as the IPT Standard Specifications for Tablet-
ing Tools, because it had been developed by the Industrial
Pharmaceutical Technology (IPT) section of the APhA’s
Academy of Pharmaceutical Sciences. The manual is cur-
rently in its 7th edition, which was published in 2006.
With pharmaceutical manufacturing and technology
changing at an ever-increasing rate, we asked tableting
experts about the TSM’s ongoing importance to the
 Copyright CSC Publishing
industry and had them weigh in on aspects of the manual
that might need to be updated in a future edition.
What benefits does the TSM provide for
manufacturers of tablet products and
suppliers of tablet presses and tooling?
Andrew Lapinsky, engineering and CNC program-
ming manager, Elizabeth: The TSM is a great refer-
ence for the many users of tablet tooling across diverse
companies within the healthcare industry. The nuances
related to compression tooling can be daunting, and the
TSM establishes a common vocabulary and principles
for both experienced and novice users alike. Employee
mobility and turnover across the pharmaceutical industry
creates a demand for ongoing tablet manufacturing train-
ing. The TSM provides the foundation for establishing
repeatable processes and cost-effective decision making
within the industry.
Dale Natoli, president, Natoli Engineering, chairman
for the TSM’s 3rd edition, and steering committee mem-
ber for the TSM’s 7th edition: In general, the standards
provide efficiency related to manufacturing processes,
quality assurance, standard operating procedures, com-
munications, training, cleaning, and storage. Also, tooling
standards reduce variables when transferring a product
from one manufacturing site to other, international sites.
Mark Rice, technical service manager, SMI: The
TSM provides tablet manufacturers with a good resource
for troubleshooting tablet press issues as well as aiding in
tooling and custom parts design.
Luke Hoskin, technical sales manager, North Amer-
ica, I Holland: The TSM offers a clear and compre-
hensive guide to tableting principles, which have been
combined from a number of different influential industry
sources. This ensures that the information is objective
and specific to each subject area.
The TSM allows solid dose manufacturers to follow
a common operating standard, helping to ensure inter-
changeability of tooling across the various tablet press
types in use in North America. But the manual is not only
useful for tablet press users in the Americas. Global users
from time to time adopt a press made to TSM standards,
so knowledge of the standard is helpful. The general
information in the manual is also good to have available.
Nicola Pistillo, product manager, and Federica
Giatti, compression technologist, IMA Active: From
a tablet press manufacturer’s point of view, TSM tool-
ing requires a different cam configuration and assembly
specifications compared to EU tooling, so the manual is
a must for companies that supply equipment to both the
European and US markets.
From a process point of view, there is no particular
advantage to TSM tooling versus EU tooling. On the
contrary, the existence of two standards covering the
same tablet size represents an increased cost of ownership
for pharmaceutical companies.
Mike Tousey, president, Techceuticals: The TSM
standards allow for tooling interchangeability between
tablet presses. The manual also provides information on
troubleshooting, tablet designs to help strengthen tools
and withstand formulation changes, logo design, and
specific applications for coated and non-coated tablets.
The standards also allow manufacturers to establish and
track wear patterns and overcome them through tooling
design, steel selection, or both. My TSM is always next
to me, and I still have my first IPT manual from the 70s.
Todd Martin, senior tooling engineer, Wilson Tool
International and contributor to the TSM’s 7th edition:
The TSM is the essential bible for tablet tooling in North
America. I reference my dog-eared copy every day in my
work. The standards and reference information allow for
efficient design and manufacture of tooling. Consistent
standards help end users purchase tooling that works in
their machines, and press manufacturers rely on TSM
standards to provide machines that fit our market.
Do you believe the TSM is due for an update?
Natoli: I do believe the TSM is due for an update.
Even more so, the next edition has an opportunity to
be the go-to publication, with more useful information
including a reference for all tool features, modifications,
and exclusive tool configurations.
Tousey: Yes, tablet presses have changed. The TSM is
a good guide, but there is always room for improvement.
I believe the TSM should be gone through from top to
bottom and should include international standards as well
and be considered a world book. Too many think it is
just a North American book.
Pistillo and Giatti: It would be interesting to have an
update that integrated some new developments in the
market from tooling suppliers as well as tablet press man-
ufacturers. The reality of the market has changed a lot
since 2006.
Lapinsky: Yes, there have been advancements to
rotary tablet presses, tablet tooling materials and coat-
ings. These new specifications should be added.
Hoskin: Tablet manufacturing has come a long way in
the last 14 years and there have been many innovations in
tablet compression tooling and its associated maintenance
and management. These considerations make some of the
guidance in the TSM’s 7th edition a little out of date.
Additionally, perhaps now would be the ideal time to
bring the TSM into a digital format to work alongside
the more traditional workbench document. At I Holland,
we have introduced online training and believe this is the
way forward to help tablet manufacturers improve their
knowledge and skills. Putting the TSM into a similar for-
mat would allow those who follow the manual to access it
with ease.
Are any new tooling specifications needed?
Pistillo and Giatti: Back in 2006, the steering com-
mittee was focused on the pharmaceutical market. How-
ever, there are new markets that need to be investi-
gated. IMA is promoting tablet presses not only in
pharma but in the chemical and other non-pharma
 Copyright CSC Publishing
industries, where tooling specifications are completely
missing. Customers’ requests need to be fulfilled not
with TSM or EU punches but with product-specific
tooling, such as IMA32.
Frederick J. Murray, president, Korsch America:
Most of the machines listed in the document are old and,
in many cases, have been replaced with newer models
that are not referenced. There are also a number of Euro-
pean tool specifications, such as EU441 and FS12, which
have no real equivalent in the TSM. In Europe, there is
a different specification (DIN ISO 18084) to describe
and define punch and die dimensions and tolerances and
allow for exchangeability between presses from different
suppliers. An effort should be made to bring all tool spec-
ifications into a single document if at all possible, and in
the longer term, a process to harmonize tooling specifica-
tions should be considered.
With regard to current TSM standards, the upper key
position on the punch barrel should be fully defined for
all tool configurations. This can be a critical consider-
ation, and the arbitrary placement of the key position can
cause interference with the oil seal and risk lubricant con-
tamination on the die table.
Martin: I would suggest adding BBS die specifications
and updating the press tables as follows:
• Indicate whether the press has punch seals;
• Specify key location range per model (X-min. and
Y-max. from Table 4 on page 40);
• Specify upper punch penetration per model; and
• Specify minimum lower punch pull-down value.
Lapinsky: The common punch head configurations for
type B and D punches should be reviewed for additions
to the TSM domed head profile. There are one or two
domed punch head profiles that are considered standard,
but they have not been added to the TSM. These head
profiles increase the punch head flat. A question should
be asked if die segments need to be added to the standard
TSM die line of (0.945”, 1-3/16” & “D”). Also, information
about automated polishing machines should be added.
Natoli: New tooling standards may not be required,
but the manual should identify and explain innovative
and accepted tooling options, such as extended head
flats, special lower tip reliefs, and multi-tip tooling, that
do not conform to the published standards relative to
tablet press operation and product quality.
Hoskin: Tooling specification is very similar to a
decade ago. However, as with all engineering refine-
ment, incremental change is the driver. It is important to
account for these incremental changes—for example, die
segment technology and micro die tapers—in the manual.
Multi-tip tooling has advanced rapidly. As mass-pro-
duction of tablets grows, multi-tip tooling is helping to
transform the way tablets are produced by increasing
production without requiring investment in new machin-
ery or operator hours. Information on multi-tip setup pro-
cedures as well as general information on the setting of
presses using this tooling is essential.
Jennifer McGonigle, director of operations, SMI:
Specifications and an instructional section discussing the
use of single and multi-tip tooling for minitablet produc-
tion would be very beneficial.
Which existing specifications
should be revised and how?
Tousey: There are many, including clearances, head
flats, and tolerances. Also, many new copies of tablet
presses have come out with new and different punch and
die configurations. The steering committee would need
to determine whether these presses should be included.
Martin: I would recommend the following revisions to
existing specifications:
• Update Figure 37 to include D3 steel;
• Update Figure 40 (Quote/Order Form) to indicate
a specific tool material (such as S7 or D2 steel)
rather than “standard” or “premium;”
• Change the surface finish tolerance from “±” to a
maximum value, as tools should not be rejected due
to a surface finish that is too good;
• Correct the “BB” die O.D. dimension tolerance
from +.0005”/-0 to +0/-.0005;”
• Remove Note 3 regarding the Stokes GEM
Supreme stem length—incorrect (B & D);
• Correct Table 3 (Standard Clearances) 5/32” metric
value from 3.3970 millimeters to 3.969 millimeters;
and
• Clarify 408 steel force rating (the text says 10 per-
cent less than S7, while Figure 36 shows higher
toughness than S7).
Hoskin: There are now many more options in terms
of punch head forms to increase desirable features such as
dwell time without slowing down press speed or upsizing
punches. Also, new innovations in tool steel, coatings, and
treatments have been specifically tailored to provide wear
and corrosion resistance or improve anti-stick properties.
These developments have changed tablet manufacture
significantly by addressing challenging formulations or
production issues and have improved tableting efficiency.
Other procedures that should be updated and added
to include anti-stick guidance and tooling maintenance.
Planned, professional tooling maintenance, management,
and storage is fundamental to achieving optimal equip-
ment efficiency and tablet output.
Natoli: The standard TSM angled head configura-
tion should be eliminated in lieu of the domed head for
extended tooling life and smooth tablet press operation.
Lapinsky: Tables 5-8, which cover interchangeable
tooling for rotary tablet presses, should be updated to indi-
cate the newer tablet presses in the market. There is a need
to add tolerances to the seal groove formation. This would
help establish a profile of size range to ensure that all tool
manufacturers’ European dust cup reliefs (seal grooves)
meet the TSM specifications. Also, bisects should be cate-
gorized as functional or non-functional, and more informa-
tion from the FDA should be added to that section.
 Copyright CSC Publishing

Pistillo and Giatti: Tooling specifications might • Recognizing exclusive tool configurations as an
need to be revised to include analysis of new technolo- alternative to standard dies.
gies applied to force calculation—such as finite element Pistillo and Giatti: A study comparing the character-
method (FEM)—that include the effects of the material istics of tablets compressed using TSM punches to tab-
and coating on the final result. lets compressed using EU punches would give users an
Regarding tablet press specifications, new companies idea of the effective advantages of each standard on the
and tablet press models are in the market. Also, tablet tableting process. Insight into multi-tip tooling applica-
presses that use centrifugal force feeding, such as the tions is missing as are studies comparing blend feeding
IMA Comprima, have not been taken into account. systems, which strongly affect tablet quality. Also, exter-
Compatibilities between materials in contact with nal lubrication technology is now available, fulfilling mar-
the formulation and the most recognized APIs should be ket requests to help ease challenging processes and meet
revised. It might be interesting to have suggestions for the needs of the trend toward continuous manufacturing.
coatings/tip materials depending on the API or excipi- Hoskin: Continuous manufacturing is a big area of
ent characteristics as well as advice for handling abrasive change in tableting and should certainly be addressed,
compounds. The same approach could be used for the including best practices, solutions, and technology to help
troubleshooting section, which could include more dis- with implementation. Examples of this are tool steel and
cussion covering the most commonly found tablet defects. coating choices that should be used for continuous tablet-
ing and specialized tooling that can help achieve more
Should any new topics be added to the TSM? reliable run times. Other topics that deserve space are
Martin: I would recommend adding the following: tooling maintenance programs and management systems
• Guidance on the proper take-off position for differ- and scientific research relevant to tablet manufacture. T&C
ent tablet shapes (keying angle for polygons);
• A new section on minitablet tooling; The Tableting Specification Manual is available for pur-
• FEA guidance for determining force ratings (such as
chase at: ebusiness.pharmacist.com/PersonifyEbusiness/Shop-
Von Mises versus maximum principal stress, mesh
size, and endurance limits); APhA/Product-Details/productId/115810.
• Include maximum force values for punch head
profiles; Elizabeth, McKeesport, PA
• Include guidance on which presses need keyed 412 751 3000
rounds to prevent double impressions (from eliz.com
insufficient anti-turning between pre- and main
I Holland, Nottingham, UK
compression).
+44 115 972 6153
Tousey: I would like to see a comprehensive section
tablettingscience.com
on wear issues. There are significant differences between
older tablet presses and current machines that should be
IMA North America, Leominster, MA
recognized and defined in the TSM. For instance, lower
978 537 8534
punch diameters have changed, but the TSM doesn’t
www.ima.it
explain that the change has to do with the introduction
of punch seals and may not benefit companies using older
Korsch America, South Easton, MA
machines. The original smaller diameter barrels allowed
508 238 9080
more clearance to reduce the potential for binding. The
www.korsch.com
distinction should be clear, so manufacturers that have
some older machines and some newer machines will
Natoli Engineering, St. Charles, MO
understand how changing to “current” standards may
636 926 8900
impact performance.
natoli.com
The TSM is an important tool; too many manufacturers
rely solely on the tooling supplier to interpret their appli- SMI, Bethlehem, PA
cation and their vintage and mix of tablet presses. This has 908 534 1500
a direct impact on tablet quality and productivity. www.smitmc.com
Natoli: New topics that would be beneficial for a new
edition include: Techceuticals, Cleveland, OH
• A more comprehensive and updated troubleshoot- 216 658 8038
ing guide; www.techceuticals.com
• A better understanding of clearances between the
tablet compression tooling and the tablet press; Wilson Tool, White Bear Lake, MN
• A better understanding of clearances between the 800 467 8444
punch tip and the die; and www.wilsontool.com